All pharmaceuticals and medical devices sold in the United States are subject to FDA regulations. Smart packaging as a track and trace technology platform for the biomedical industry that simultaneously solves the critical problems of counterfeiting and inefficient recalls is needed in the industry. The annual global market for pharmaceuticals in 2006 was $500 billion. In 2006, $40 billion was lost to counterfeit products globally, and that number was projected to reach $75 billion by 2010. Bio-pharma paperboard packaging is projected to grow 5% year-over-year and to reach $730 million by 2015. A recall of products in 2010 cost Johnson & Johnson $600 million. In September and October of 2012, 404 people were infected and twenty-nine people died from a meningitis outbreak that led to a total recall of all Ameridose products. The liabilities and expense from this recall are not yet known. It is known that as a result, Ameridose has notified 790 employees of pending layoffs, including 140 employees of an affiliated marketing company. Track and trace technologies have potential to reduce losses due to counterfeit products, manage recalls more efficiently in an effort to protect consumers and to reduce negative economic impacts, comply with FDA regulations, and provide relevant information to consumers in real time. Beyond drugs and medical devices, track and trace can be extended to food and other FDA-regulated products, as well as consumer electronics and practically anything that can be sold in a deceptive or broken state.
The FDA Amendments Act of 2007 promised track and trace guidelines but failed to deliver them. In the absence of guidelines there is inertia among bio-pharma companies and other organizations to adopt track and trace technology. Therefore, they need a technology that is future-proof, one that can be readily changed to meet the requirements of new regulations.
Therefore, it would be an advancement in the state of the art to provide a track and trace application for biomedical products that addressed the pressing needs of industry and the FDA. It is against this background that the various embodiments of the present invention were developed.